Senior Quality Engineer: Failure Analysis & Reliability

BD; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD, a leading medical technology company, is seeking a senior quality engineer focused on failure analysis in the Irvine, CA area. You will lead investigations into product failures and customer complaints, conduct in-depth root cause analyses, and communicate findings through detailed reports.

Collaborate with cross-functional teams to drive CAPA and improve product reliability. Ideal candidates have 5+ years in medical device quality, strong knowledge of regulatory standards (FDA 21 CFR Part

Qualifications

• Bachelor's degree in Engineering or related field; Master’s preferred.
• 5+ years of experience in quality engineering with a focus on failure analysis within medical devices.
• Expertise in FMEA, 8D, Ishikawa; microscopy, FTIR, SEM/EDX, DPA, X-ray.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, MDR.
• Ability to lead technical investigations and provide data-driven conclusions.
• Excellent written and verbal communication; cross-functional collaboration.
• ASQ CQE/CRE is a plus; Six-Sigma Black Belt is a plus.

Responsibilities

• Lead and conduct failure analysis investigations on returned products, complaints, and manufacturing nonconformances.
• Perform root cause analysis using structured methodologies (8D, 5-Why, Fishbone, FMEA).
• Develop and execute plans to identify failure mechanisms and validate root causes.
• Use lab equipment and analytical tools to evaluate performance and failure modes.
• Author comprehensive technical reports communicating methods, evidence, findings, and recommendations.
• Support complaint handling investigations and identify recurring failure modes.
• Analyze data to identify quality and reliability improvement opportunities.
• Collaborate with cross-functional teams to implement CAPA.

Skills

Failure analysis

Root cause analysis

CAPA

Regulatory knowledge

Statistical software

Six-Sigma Black Belt

Communication

Team leadership

FMEA

Ishikawa

X-ray

Microscopy

FTIR

SEM/EDX

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Microscopy

FTIR

SEM/EDX

X-ray

Job description

BD, a leading medical technology company, is seeking a senior quality engineer focused on failure analysis in the Irvine, CA area. You will lead investigations into product failures and customer complaints, conduct in-depth root cause analyses, and communicate findings through detailed reports.

Collaborate with cross-functional teams to drive CAPA and improve product reliability. Ideal candidates have 5+ years in medical device quality, strong knowledge of regulatory standards (FDA 21 CFR Part